Taperloc Complete Primary Femoral 51-104140Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Taperloc Complete Primary Femoral (40)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Biomet Taperloc hip stem, the metal implant used in hip replacement surgery. Most of its 43 reports describe sterile packaging problems — torn or punctured pouches found during stock inspections, plus items arriving unsterile or contaminated. Most involved no patient; there were 2 injuries and no deaths. No recalls name this device. Reports fell from 23 in the prior 12 months to 5 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00880304491847), received between May 7, 2020 and Sep 2, 2026 — classified as 2 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (13 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Tear, Rip or Hole in Device Packaging13
- Manufacturing, Packaging or Shipping Problem10
- Packaging Problem10
- Delivered as Unsterile Product4
- Device Contaminated During Manufacture or Shipping4
- Difficult to Insert2
- Peeled/Delaminated2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- No Patient Involvement3
- Ambulation or Postural Difficulties1
- Foreign Body In Patient1
- Pain1
- Unequal Limb Length1
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50571116 ↗MalfunctionAug 10, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
It was reported that damaged sterile packaging was identified during stock inspection.There was no patient involvement.Attempts have been made and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50191523 ↗MalfunctionApr 8, 2026Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING AN INTERNAL STOCK INSPECTION, A STERILE PACKAGE WAS FOUND DAMAGED. THE AFFECTED ITEM WAS IDENTIFIED IN CIRCULATED INVENTORY AND NOT USED CLINICALLY. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24817374 ↗MalfunctionFeb 23, 2026Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24415843 ↗MalfunctionNov 6, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23487252 ↗MalfunctionOct 24, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23383642 ↗MalfunctionOct 22, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23360427 ↗MalfunctionAug 6, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT WHILE INSPECTING CIRCULATED ITEMS, IT WAS FOUND THAT THE STERILE PACKAGING WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT, AND IT WAS REPORTED NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22725123 ↗MalfunctionJul 7, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE STERILE PACKAGING WAS DAMAGED DURING INSPECTION OF THE CIRCULATED ITEMS. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22414177 ↗MalfunctionJul 7, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE STERILE PACKAGING WAS DAMAGED DURING INSPECTION OF THE CIRCULATED ITEMS. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22414164 ↗MalfunctionJul 3, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE STERILE PACKAGING WAS DAMAGED DURING INSPECTION OF CIRCULATED ITEMS. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22397128 ↗MalfunctionJul 1, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DAMAGED STERILE PACKAGING WAS IDENTIFIED IN THE WAREHOUSE DURING THE INSPECTION OF CIRCULATED STOCK ITEMS. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22375599 ↗InjuryJun 25, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT DURING AN INITIAL HIP PROCEDURE, THE SURGEON IMPACTED THE DISTAL STEM AND THEN EXTRACTED THE IMPLANT USING THE STANDARD SURGICAL TECHNIQUE. UPON EXTRACTION, IT WAS OBSERVED THAT THE BEADS ON THE POROUS COATING WERE FLAKING OFF. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 22327659 ↗MalfunctionJun 13, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT WHILE INSPECTING CIRCULATED ITEMS, IT WAS FOUND THAT THE STERILE PACKAGING WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT, AND IT WAS REPORTED NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22201764 ↗MalfunctionJun 4, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT WHILE INSPECTING THE PACKAGING, THE STERILE PACKAGING WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22140078 ↗MalfunctionMay 9, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED DURING INSPECTION THAT THE STERILE PACKAGING OF THE CIRCULATED ITEMS WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21994610 ↗MalfunctionMay 2, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT WHILE INSPECTING THE PRODUCT, THE STERILE PACKAGING WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21951271 ↗MalfunctionMay 2, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT WHILE INSPECTING THE PRODUCT, THE STERILE PACKAGING WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21949836 ↗MalfunctionApr 21, 2025Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT WHILE INSPECTING STOCK, THE INNER POUCH OF THE PACKAGING WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21876071 ↗MalfunctionMar 25, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED WHILE INSPECTING THE BOX AT THE DISTRIBUTORSHIP, THE STERILE PACKAGING WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21686628 ↗MalfunctionMar 25, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21686575 ↗MalfunctionMar 14, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE CIRCULATED ITEMS WERE INSPECTED AND THAT THE STERILE PACKAGING WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21604714 ↗MalfunctionMar 12, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS PRODUCT STERILITY WAS NOT BREACHED. THE INITIAL REPORT SHOULD BE VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21584882 ↗MalfunctionMar 12, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE CIRCULATED ITEMS WERE INSPECTED, AND THE STERILE PACKAGING WAS DETERMINED TO BE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21584451 ↗MalfunctionMar 6, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THE CIRCULATED ITEMS WERE INSPECTED AND IT WAS IDENTIFIED THAT THE STERILE PACKAGING WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21539384 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page